When reviewing a proposal, will the IRB consider the soundness of the research methodology?
Yes. Although the IRB’s primary focus is on the ethical aspects of the research, the IRB is required by regulations to determine that “the research design is scientifically sound and does not expose subjects to unnecessary risk.” In addition, in order to approve a proposal, the IRB must also determine that the benefits of the research outweigh any risks to participants. Thus, the IRB must be able to make a determination that the research design will yield beneficial information. If the research design is so flawed that it will not yield useful information and there is more than minimal risk to participants, then the benefits do not outweigh the risks and the research may not be approved. • Under what conditions must I continue to submit annual renewal applications for purposes of Continuing Review? Annual Continuing Review applications must be submitted as long as research-related interventions or interactions with human subjects are on-going or as long as data collection and analysis
Related Questions
- What is to prevent the University from requiring researchers to pay this fee for reviewing IRB applications for research that is supported by non-sponsored funding?
- Is it ethical for an IRB to charge a potential sponsor a fee for the review of a research proposal?
- When am I required to submit a proposal involving research with human participants to the IRB?
